Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (ACCESS II)

February 16, 2021 updated by: Galderma R&D

Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada
        • Galderma Investigational Site
      • North Bay, Ontario, Canada
        • Galderma Investigational Site
      • Windsor, Ontario, Canada
        • Galderma Investigational Site
    • Quebec
      • Quebec City, Quebec, Canada
        • Galderma Investigational Site
  • Puerto Rico
      • Aibonito, Puerto Rico
        • Galderma Investigational Site
      • Carolina, Puerto Rico
        • Galderma Investigational Site
  • United States
    • California
      • San Diego, California, United States
        • Galderma Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Galderma Investigational Site
      • Longmont, Colorado, United States
        • Galderma Investigational Site
    • Florida
      • Miami, Florida, United States
        • Galderma Investigational Site
    • Georgia
      • Snellville, Georgia, United States
        • Galderma Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Galderma Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • Galderma Investigational Site
    • Kansas
      • Overland Park, Kansas, United States
        • Galderma Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Galderma Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • Galderma Investigational Site
      • Fort Gratiot, Michigan, United States
        • Galderma Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States
        • Galderma Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Galderma Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Galderma Investigational Site
    • New York
      • Stony Brook, New York, United States
        • Galderma Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Galderma Investigational Site
    • Ohio
      • Warren, Ohio, United States
        • Galderma Investigational Site
    • Pennsylvania
      • Hazleton, Pennsylvania, United States
        • Galderma Investigational Site
      • Hershey, Pennsylvania, United States
        • Galderma Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, United States
        • Galderma Investigational Site
    • Texas
      • Arlington, Texas, United States
        • Galderma Investigational Site
      • Austin, Texas, United States
        • Galderma Investigational Site
      • College Station, Texas, United States
        • Galderma Investigational Site
      • Houston, Texas, United States
        • Galderma Investigational Site
      • Lubbock, Texas, United States
        • Galderma Investigational Site
      • San Antonio, Texas, United States
        • Galderma Investigational Site
      • Webster, Texas, United States, 77598
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning a pregnancy during the study
  • Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
Topical Gel to the face, once daily in the evening for 24 weeks.
Other Names:
  • Adapalene-BPO gel
Placebo Comparator: 2
Vehicle Gel once daily
Drug: Vehicle Gel
Topical Gel to the face, once daily in the evening for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance Success for Total Lesions at Week 24
Time Frame: Week 24
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance Success for Inflamatory Lesions at Week 24
Time Frame: Week 24
Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.
Week 24
Maintenance Success for Non-inflammatory Lesions at Week 24
Time Frame: Week 24
Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.
Week 24
Investigator Global Assessment (IGA) Maintenance Success at Week 24
Time Frame: Baseline, Week 24

IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.

IGA grade:

0 Clear:Residual hyperpigmentation & erythema may be present

  1. Almost Clear:A few scattered comedones & a few small papules.
  2. Mild:Some comedones & some papules and pustules. No nodules present
  3. Moderate:Many comedones, papules & pustules. One nodule may be present
  4. Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present
  5. Very severe:Highly inflammatory acne covering the face; with nodules & cysts present
Baseline, Week 24
Percent of Subjects With Adverse Events
Time Frame: Up to 24 weeks
All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Diane Thiboutot, MD, Penn State College of Medicine, Hershey, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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